Research Governance: Site File, Monitoring, Audit, Adverse Event Reporting

It is recommended that you use the downloadable documents opposite if the University is your project's research governance sponsor - i.e.:

  1. establish a site file which, as a minimum, contains the content in the template provided opposite;
  2. report progress to your Head of Department (for example 3 months after starting, annually, at the end);
  3. report adverse events to the Head of Department, and to the University's Research Services (should they occur).

If your project was ethically approved by an NHS Research Ethics Committee (REC) then within 90 days of the project's end (or within 15 days if the project is terminated early) you need to inform the REC of the project's end.